Occlusion implant

ABSTRACT

Contraceptive and/or sterilization methods and devices are disclosed which may improve the speed of tubal occlusion and mechanisms for anchoring for a contraceptive device. In accordance with some embodiments, improvements may be made to the delivery catheter to induce trauma and create faster tubal occlusion, improvements may be made to the occlusion device to prevent migration and induce trauma, and improvements may be made to the occlusion device to reduce the total volume of in-growth required compared to conventional expansive occlusion devices.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/113,456, filed Nov. 11, 2008.

BACKGROUND

Embodiments of the present invention relate to the field of permanenttubal occlusion. More specifically, embodiments are directed to a deviceand method for placement of an occlusion device into a fallopian tube toachieve permanent occlusion. Conventional contraceptive strategiesgenerally fall within three categories: physical barriers, drugs andsurgery. While each have certain advantages, they also suffer fromvarious drawbacks. Barriers such as condoms and diaphragms are subjectto failure due to breakage, displacement and misuse. Drug strategieswhich rely on artificially controlling hormone levels suffer from knownand unknown side-effects from prolonged use. Finally, surgicalprocedures, such as tubal ligation and vasectomy, involve the costs andattendant risks of surgery and are frequently not reversible.

In response to the aforementioned difficulties and inefficiencies ofconventional contraceptive strategies, a number of implantable andpermanent sterilization products have been developed to physically blockthe passage of reproductive cells between the ovary and uterus.Generally, these implantable permanent sterilization products arepositioned within the fallopian tube so as to promote tissue in-growth,and over time, they physically occlude the fallopian tube.

While such implantable sterilization products are effective andminimally invasive, still further improvements would be desirable. Forinstance, it would be desirable to provide an occlusion device thatreduces the requisite in-growth area to create the desired fallopiantube blockage. It would be desirable to provide an occlusion devicehaving improved structures and/or mechanisms for anchoring the device.Further, it would be desirable to provide a system to provide enhancedtrauma inducement within the musculature layer of the fallopian tube toincrease the level of fibro-proliferative tissue response thatultimately enables tissue in-growth. Some or all of these advantages areprovided by the devices and methods described hereinbelow.

SUMMARY

Embodiments of the present invention generally provide improvedcontraceptive and/or sterilization methods and devices. Embodimentsgenerally improve the speed of tubal occlusion and mechanisms foranchoring for a contraceptive device.

In one embodiment of the present invention, the occlusion device is atleast in part expandable within a body lumen from a first configurationsuitable for insertion into the chosen location within the body lumen,to a second configuration larger than the first configuration tofacilitate fastening of the occlusion device to the wall of the bodylumen and creating an obstruction to block the body lumen.

In accordance with some embodiments, improvements may be made to thedelivery catheter to induce trauma and create faster tubal occlusion.The delivery catheter may have an elongated shaft having a distal endportion and a lumen extending therein with an occlusion devicerestrained within the lumen. A surface of the distal end portion of theelongated shaft may include a plurality of shark skin oriented textures.The textures allow for smooth entry of the elongated shaft into a bodylumen such as a fallopian tube, whereas retraction of the elongatedshaft of out of the fallopian tube causes trauma to the fallopian tubewhich may promote the healing response and tissue in-growth into thedeposited occlusion device.

The delivery catheter may include an elongated shaft which is equippedwith features which can be expanded from and retracted back into theelongated shaft. For example, the elongated shaft may have a distal endportion and a lumen extending therein. A slit is provided in the distalend portion of the elongated shaft, with a wire that is expandablethrough and retractable into the slit. The wires may be expanded out ofthe elongated shaft prior to or during delivery of the occlusion deviceto induce trauma to the fallopian tube, and retracted into the elongatedshaft prior to removing the catheter from the fallopian tube to avoidtrauma to the ostium.

In accordance with some embodiments, improvements may be made to theocclusion device to prevent migration and induce trauma. The occlusiondevice may have a tubular frame member including protruding featuresattached the frame in a helical arrangement to resist displacement bythe natural peristaltic pumping forces within a fallopian tube. Theocclusion device may have an open framework comprising triangular ordiamond-like shapes having closed ends that face outward proximally,distally and radially from the occlusion device to create engagementanchors in a starburst-like configuration. The occlusion device maycomprise a series of linked ovals which, when deployed are folded withina middle portion of the device and not folded at the proximal and distalend portions of the device.

The occlusion device may include a proximal portion, a distal portion,and a traverse member connecting the proximal portion and the distalportion, a first plurality of arms outwardly expandable from theproximal portion of the occlusion device, and a second plurality of armsoutwardly expandable from the distal portion of the occlusion devicesuch that the first plurality of arms and second plurality of arms areexpandable in opposition directions and overlap when expanded. Thetraverse frame member may be contractible or rigid.

In accordance with some embodiments, improvements may be made to theocclusion device to reduce the total volume of in-growth requiredcompared to conventional expansive occlusion devices. The occlusiondevice may include a tubular frame member and a rod disposed within andrunning through the center of the tubular frame member, with the rodfilling at least half of the cross-sectional area of the tubular framemember when in the expanded configuration. The occlusion device may havean open walled frame, where the frame can be constrained within acatheter in a rolled up configuration and deliverable within a fallopiantube in a substantially flat configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a delivery catheter in accordance with an embodimentof the present invention.

FIG. 2 illustrates the female anatomy for deployment of thecontraceptive devices in accordance with embodiments of the presentinvention.

FIG. 3 illustrates the male anatomy deployment of the contraceptivedevices in accordance with embodiments of the present invention.

FIG. 4 illustrates a cross-sectional view of a delivery catheter inaccordance with an embodiment of the present invention.

FIG. 5A illustrates a side view of a delivery catheter in accordancewith an embodiment of the present invention.

FIG. 5B illustrates a cross-sectional view of a delivery catheter ofFIG. 5A in accordance with an embodiment of the present invention.

FIG. 6-FIG. 10A illustrate side views of occlusion devices in accordancewith embodiments of the present invention.

FIG. 10B illustrates a cross-sectional view taken along line A-A of theocclusion device illustrated in FIG. 10A in accordance with embodimentsof the present invention.

FIG. 11A illustrates a side view of an occlusion device in accordancewith an embodiment of the present invention.

FIG. 11B illustrates a top view of FIG. 11A in accordance with anembodiment of the present invention.

FIG. 12A illustrates a top view of an occlusion device in accordancewith an embodiment of the present invention.

FIG. 12B illustrates a side view of FIG. 12A in accordance with anembodiment of the present invention.

FIG. 12C illustrates an isometric view of FIG. 12A in accordance with anembodiment of the present invention.

FIG. 12D illustrates a side view of an occlusion device in accordancewith an embodiment of the present invention.

FIG. 12E illustrates a top view of an occlusion device in accordancewith an embodiment of the present invention.

FIG. 13A illustrates a side view of an occlusion device in accordancewith an embodiment of the present invention.

FIG. 13B illustrates a cross-sectional view of FIG. 13A in accordancewith an embodiment of the present invention.

FIG. 13C-FIG. 13D illustrate isometric views of FIG. 13A in accordancewith embodiments of the present invention.

FIG. 14A-FIG. 17B illustrate side views of occlusion devices inaccordance with embodiments of the present invention.

FIG. 18A-FIG. 18B illustrate cross-sectional views of occlusion devicesin accordance with embodiments of the present invention.

FIG. 18C-FIG. 18E illustrate isometric views of occlusion devices inaccordance with embodiments of the present invention.

FIG. 19A illustrates a top view of an occlusion device in accordancewith an embodiment of the present invention.

FIG. 19B-FIG. 19C illustrate isometric views of occlusion devices inaccordance with embodiments of the present invention.

DETAILED DESCRIPTION

Embodiments of the present invention generally provide improvedcontraceptive and/or sterilization methods and devices. Morespecifically, some embodiments provide an occlusion device and methodwhich can be used to inhibit pregnancy, typically for the long-terminhibition of pregnancy, and often providing permanent contraception orsterilization.

Various embodiments and aspects will be described with reference todetails discussed below and the accompanying drawings will illustratethe various embodiments. The following description and drawings areillustrative of the invention and are not to be construed as limitingthe invention. Numerous specific details are described to provide athorough understanding of various embodiments of the present invention.However, in certain instances, well-known or conventional details arenot described in order to provide a concise discussion of embodiments ofthe present invention.

FIG. 1 is an illustration of a delivery catheter 1 useful in thedelivery of an occlusion device 10 in accordance with embodiments of thepresent invention. Delivery catheter 1 generally comprises an elongatedshaft 2 having a lumen 3 extending therein. The occlusion device 10 maybe self expanding. For example, occlusion device 10 may be deformed intoa smaller configuration when within the lumen 3 of the deliverycatheter, and expanded into a larger configuration within a body lumenby longitudinally displacing the occlusion device 10 out of the distalend of the delivery catheter. A pusher 4 with an enlarged head 5slidably received within the lumen 3 of the delivery catheter can beused to longitudinally displace the occlusion device 10 out of thedistal end of the delivery catheter.

Over-the-wire (OTW) designs or techniques may additionally be utilizedto deliver occlusion devices in accordance with embodiments of thepresent invention. Placement of the occlusion device may be madedirectly or with the use of another device, for example a hysteroscopeor other type of laparascope. Those skilled in the art will recognizethat various combinations, modifications and alternative embodiments maybe equivalents and may be included in the invention without departingfrom the scope of the invention as set forth herein. For example, otheracceptable variations of the delivery devices and the occlusion devicesare disclosed in patent application Ser. No. 08/770,123, filed on Dec.18, 1996, now U.S. Pat. No. 7,037,504; Ser. No. 09/112,085, filed Jul.8, 1998, now U.S. Pat. No. 6,0906,052; Ser. No. 09/468,749, filed onDec. 21, 1999, now U.S. Pat. No. 6,432,116; Ser. No. 11/048,237, filedFeb. 1, 2005; Ser. No. 10/746,131, filed Dec. 24, 2003; Ser. No.10/972,857, filed Oct. 25, 2004; Ser. No. 10/880,355, filed Jun. 28,2004; Ser. No. 09/911,551, filed Jul. 23, 2001; Ser. No. 12/035,219,filed Feb. 21, 2008; Ser. No. 11/695,887, filed Apr. 3, 2007; Ser. No.11/048,221, filed Jan. 31. 2005; and Prov. No. 61/113,456 filed Nov. 11,2008 the complete contents of which are incorporated as if set forth infull herein.

FIG. 2 is an illustration of an occlusion device 10 implanted into afallopian tube F of a female patient. A delivery catheter 1 can beinserted through cervix C, into the uterus U, and guided into afallopian tube F through a tubal ostium O. Once the precise locationwithin the fallopian tube is reached, the occlusion device 10 isreleased. Occlusion device 10 may also be inserted into other bodylumens such as the vas deferens 8 of the male reproductive anatomy, asillustrated in FIG. 3.

In accordance with some embodiments of the present invention,improvements may be made to a delivery catheter to induce trauma andcreate faster tubal occlusion. Tissue trauma may be generated byfeatures of the delivery catheter in order to create a greater tissuehealing response. In an embodiment illustrated in FIG. 4, the outersurface of elongated shaft 2 of delivery catheter 1 is provided with ashark skin, or oriented textures 12 near a distal end of elongated shaft2. As illustrated in FIG. 4, the shark skin, or oriented texture 12 hasthe appearance of a first dorsal fin having a triangular shape. In anembodiment, leading edge 13 and trailing edge 15 of the oriented texture12 are flat. In another embodiment, leading edge 13 and trailing edge 15may have a curved, streamlined shape. The texture 12 allows for smoothentry into a fallopian tube in the direction of the arrow, whereasretraction of the delivery catheter in the opposite direction results intrauma to the inside of the tube.

In an embodiment, a delivery catheter comprising elongated shaft 2 ofFIG. 4 is advanced within a fallopian tube with the leading distal endof the elongated shaft being advanced to or beyond the projecteddelivery site of the occlusion device. The delivery catheter is thenretracted creating trauma at the projected delivery site, and theocclusion device is expelled at the projected delivery site. The traumacreated during retraction of the delivery catheter may promote thehealing response and tissue in-growth into the deposited occlusiondevice, resulting in faster tubal occlusion.

In an embodiment illustrated in FIG. 5A and FIG. 5B an elongated shaft 2of delivery catheter 1 may be equipped with one or more features 14 thatmay expand to cause trauma and retract back into the elongated shaft 2prior to or during withdrawal of the delivery catheter from the patient.In an embodiment, features 14 are wires that expand through slits 16 ina distal end portion of elongated shaft 2. Wires 14 can be expanded, forexample by pushing the wires 14 forward distally in elongated shaft 2,to induce trauma before or while the occlusion device is deployed, andretracted, for example by withdrawing the wires 14 proximally inelongated shaft 2, prior removing the delivery catheter 1 from thefallopian tube to avoid trauma to the ostium. In an embodiment, thewires 14 can be expanded to form an apex 17 to induce trauma.

The delivery catheters 1 in accordance with embodiments of the inventioncan be used to deliver a variety of occlusion devices such as, but notlimited to those illustrated in FIGS. 6-19C. For example, FIGS. 6-7illustrate a tubular self-expanding occlusion device 10 which comprisesa length of metal tubing such as a shape memory nitinol having slots 22.The occlusion device 10 may conform to a relatively small dimensionedconfiguration for introduction and advancement into the patient's bodylumen as illustrated in FIG. 7, and expand to a larger, openconfiguration when deployed within a body lumen as illustrated in FIG.6. The slots 22 cut into the wall of the tubing allow self-expansion ofthe occlusion device 10 into the open configuration of FIG. 6.

FIG. 8 and FIG. 9 illustrate an occlusion device 10 including a coil 28of shape memory wire or ribbon, such as nitinol. The coil 28 may conformto a relatively small dimensioned configuration for introduction andadvancement into the patient's body lumen as illustrated in FIG. 9 andexpand to a larger, open configuration when deployed within a body lumenas illustrated in FIG. 8.

FIGS. 10A an 10B illustrate an occlusion device 10 generally comprisinga tubular member 31 with an open framework, which may be restrained in arelatively small dimensioned configuration for the introduction andadvancement into the patient's body and self-expand into a larger, openconfiguration when deployed as illustrated in FIG. 10A and FIG. 10B.Occlusion device 10 has a first end 32, a second end 33 and a lumen 34extending therein. As shown in FIG. 10B illustrating a transverse crosssection of the tubular member 31 shown in FIG. 10A, taken along linesA-A, a tissue in-growth member 35 may be transversely disposed on,within or entangled with tubular member 31.

Tissue in-growth member 35 may be permeable to allow for tissuein-growth. The permeability of the tissue in-growth member 35facilitates epithelialization, and the epithelialized tissue in-growthmay permanently occlude the reproductive body lumen sufficiently toprevent the passage of reproductive cells therethrough. In anembodiment, tissue in-growth member 35 comprises fibers, which may bebundled or woven strands, or a mesh of bundles or woven strands. In anembodiment, member 35 may comprise a sheet of woven material disposed ontubular member 31 or in the lumen 34 of tubular member 31. A variety ofmaterials may be used to form the tissue in-growth member 35, includingplastics, polymers, metals, and treated animal tissues. For example,in-growth member 35 may include polyethylene terephthalate (PET) or silkfibers. In an embodiment, tissue in-growth member 35 is an irritant,such as PET or Nylon, which promotes epithelialization. Additionally,tissue in-growth member 35 may be coated or otherwise impregnated withcell growth stimulators, hormones, and/or chemicals to enhance tissueimpregnation.

While tissue in-growth member 35 is illustrated and describedspecifically with regard to FIG. 10A and FIG. 10B, it is understood thattissue in-growth member 35 can be utilized with other embodiments of theinvention, including the occlusion devices illustrated in the remainderof FIG. 6-FIG. 19C. Accordingly, while tissue in-growth member 35 maynot be illustrated or described for each of FIG. 6-FIG. 19C, it isunderstood that this omission has been made in order to more clearlyillustrate and not obscure other aspects in accordance with embodimentsof the present invention.

In accordance with some embodiments of the present invention,improvements may be made to an occlusion device to prevent migration andinduce trauma. In an embodiment illustrated in FIG. 11A-11B, occlusiondevice 10 comprises an expandable frame that has features to both engagea body lumen to prevent migration and induce trauma within the bodylumen. As shown, the occlusion device 10 has an open frameworkcomprising triangular or diamond-like shapes. Occlusion device 10 mayhave a general tubular shape, with the closed ends 36 of the triangularor diamond-like shapes facing outward from the occlusion device 10 inradial, proximal and distal directions in a starburst-like configurationto create engagement anchors, which may function to prevent migrationand induce trauma within a body lumen, such as a fallopian tube. Asprovided in the side view illustration of FIG. 11A, occlusion device 10may be characterized by rows of stacked diamond-like shapes, with theadjacent rows being connected with traverse members 38. Traverse member38 connects a side end 37 of a diamond-like shape opposite the closedend 36 to a top/bottom end 39 of a diamond-like shape. As illustrated,traverse members 38 may be periodically disposed. A period of everyother diamond-like shape is illustrated in FIG. 11A-11B, thoughembodiments include other periods of one or greater.

Occlusion device 10 may further be provided with a tissue in-growthmember similar to that in FIG. 10A and FIG. 10B. For example, occlusiondevice may be entangled with PET or silk fibers to cause a tissueresponse. Occlusion device 10 may further be provided with a membraneattached similar to the membrane illustrated in FIG. 12D to the outersurfaces to create and instantaneous occlusion.

In an embodiment illustrated in FIGS. 12A-12E, occlusion device 10comprises a series of linked ovals. FIG. 12A illustrates a top view ofthe occlusion device in a flat configuration, where FIGS. 12B and 12Cillustrate side and isometric views, respectively, of the occlusiondevice in an expanded configuration. In an embodiment, occlusion device10 may be restrained in a flat or rolled-up configuration for theintroduction and advancement into the patient's body and expand into alarger, open configuration when deployed as illustrated FIG. 12B-FIG.12D. Ovals 40 may be connected by U-shaped traverse members 42 which arealso connected at joints 47. When in the expanded configuration,connected U-shaped traverse members 42 form a folded oval shape 43 asillustrated in FIGS. 12B-12C. Ovals 40 at the proximal and distal endsof the occluding member are not folded. Trauma inducing features 44 mayadditionally be provided on the occlusion device 10, such that when inthe expanded configuration ends 45 may engage the tube to preventmigration and induce trauma within the tube.

In an embodiment illustrated in FIG. 12D a membrane 46 may be formed onthe occlusion device 10 to create a physical barrier to materialtransfer within the tube. Membrane 46 can be a variety of materials suchas, but not limited to, a polymeric sheet, closed cell foam or fabricand may be composed of a variety of layers to create an impermeablesurface or a surface that promotes tissue in-growth. In an embodiment,the membrane provides an immediate blockade to material transfer withinthe tube, providing benefits to the patient prior to the completion ofthe healing and tissue in-growth process. FIG. 12E is an illustration ofan alternative occlusion device, with additional ovals 40 and traversemembers 42.

FIGS. 13A-13D illustrate an embodiment which may both engage the tube toprevent migration and induce trauma within the tube. Occlusion device 10may include a tubular self-expanding nitinol frame 48 with protrudingfeatures 50 in a helical arrangement to engage the tubal tissue. Theocclusion device 10 may conform to a relatively small dimensionedconfiguration for introduction and advancement into the patient's bodylumen, and expand to a larger, open configuration when deployed withinthe tube. In an embodiment, the only features 50 protruding from thesurface of the frame 48 are those which are arranged in a helicalarrangement. For example, the protruding features 50 can be formed inthe shape of triangles as illustrated in FIG. 13C, or as wire-likeprongs as illustrated in FIG. 13D. The helical formation of theplurality of protruding features 50 allows the frame 48 to engage thetubal tissue and maintain the position of the occlusion member 10. It isthought that the particular helical formation of protruding features 50torques the occlusion device into the fallopian tube thereby resistingdisplacement by the natural peristaltic pumping forces. The protrudingfeatures 50 also generate a tissue healing response by causing trauma.Occlusion device 10 may further be provided with a tissue in-growthmember 35 similar to that in FIG. 10A and FIG. 10B. For example,occlusion device may be entangled with PET, silk or Nylon fibers.

FIG. 14A-17B illustrate embodiments in which the occlusion device maycomprise arms which may expand outward from the occlusion device inopposing directions to prevent migration and induce trauma. Occlusiondevice 10 may be comprised of a nitinol frame 48 that is contoured andformed to be compressed into a tube shape as illustrated in FIG. 14A,and expand such that the central arms 54 expand outward in opposingdirections offering fixation and tissue trauma means. Central arms 54may be self-expandable or may be expandable by deflection. Occlusiondevice 10 may include a proximal portion 49, a distal portion 51, and atraverse member 55 connecting said proximal portion 49 and said distalportion 51. A first plurality of arms 54 are outwardly expandable fromthe proximal portion 49, and a second plurality of arms are outwardlyexpandable from the distal portion 51 in an opposing direction to thefirst plurality of arms. The first plurality of arms and secondplurality of arms may face opposing directions and overlap in both theexpanded and restrained/compressed configurations.

In the embodiment illustrated in FIGS. 14A-14B, the proximal and distalportions of the occlusion member 10 are separated by rigid traversemember 55 located long a central axis of the occlusion device, and theoverall length of the occlusion device 10 remains the same when in therestrained/compressed and expanded states. In such an embodiment, thearms 54 may self-expand when in an unrestrained state. In an embodimentillustrated in FIG. 15A-15B, the proximal and distal ends of theocclusion device 10 are separated by a contactable traverse member 56,such as a spring. In an embodiment, the contactable traverse member 56is stretched when in a restrained/compressed position inside thedelivery catheter as illustrated in FIG. 15A. Upon delivery, the arms 54of occlusion device 10 are allowed to expand and the contactabletraverse member 56 is allowed to contract. The contracting traversemember 56 may additionally force the arms 54 outward as they aredeflected away from opposing arms 54 or other portions of the occlusiondevice 10. In an embodiment, the plurality of arms 54 are deflectedradially outward from spring 56 located along a central axis of theocclusion device 10. Arms 54 may also self-expand when unrestrained.Occlusion device 10 may further be provided with a tissue in-growthmember 35 similar to that in FIG. 10A and FIG. 10B. For example,occlusion device may be entangled with PET, silk or Nylon fibers.

FIG. 16A-16B illustrate an embodiment in which occlusion device 10 maycomprise radially expandable arms 54, spring 56 and an expandable plug60. FIG. 16A illustrates the plug 60 in an unexpanded state, such aswhen in the delivery catheter. After deployment within a body lumen, theplug 60 absorbs body fluid and radially expands to an expanded state asillustrated in FIG. 16B. The plug 60 can be formed from a variety ofmaterials such hydrogel polymers, open celled foams, etc. The additionof plug 60 allows for immediate occlusion of the body lumen. In anembodiment, plug 60 may be a cylindrical sleeve positioned over atubular extension 61 extending from said distal portion 51 along thecentral axis of the occlusion device 10.

FIG. 17A-17B illustrate an embodiment including interlocking arms 54. Inan embodiment, the proximal and distal portions 49, 51 of the occlusiondevice 10 are brought toward each other when the device isunconstrained, causing the interlocking arms 54 to expand outward fromthe frame in opposing directions to create an interlocking network ofstruts or barbs to engage the tube. The ends of the arms 54 are pushedtogether, thereby deflecting the arms 54 outward. The proximal endportion 49 and distal end portion 51 may be connected with acontractible traverse frame member 56, such as described with regard toFIG. 15A-FIG. 15B.

FIGS. 18A-19C illustrate embodiments in which the total volume ofin-growth required to occlude a body lumen may be reduced compared toconventional expansive occluding devices. An expandable tubular framemember 70 is illustrated in FIG. 18A. As illustrated in FIG. 18B apolymer or metallic rod 72 is disposed within and running through thecenter of the tubular frame 70. In an embodiment, rod 72 issubstantially solid. In an embodiment, rod 72 is impermeable. A surfaceof the rod 72 may be scored to promote tissue in-growth. Lines of tissuein-growth material 74 may also be formed on the surface of the rod 72.Tissue in-growth material 74 can be, but is not limited to, a series offibers as illustrated in FIG. 18C, a mesh as illustrated in FIG. 18D,and a porous materials as illustrated in FIG. 18E. In an embodiment, thewidth between fibers 74, pores in the mesh 74, or pore size in the meshmaterial 74 have a width W between 200 and 600 microns. The rod 72functions to fill the internal volume of the frame member 70, therebyreducing the distance that the in-growth must travel before completelyfilling all the empty space within the frame member 70. In anembodiment, rod 72 fills at least half of the cross-sectional area ofthe frame 70 as illustrated in FIG. 18B.

FIG. 19A is an illustration of an occlusion device 10 which may bedeliverable into body lumen in a substantially oblong or flat geometry.By stretching the fallopian tube in one direction, the opposing sides ofthe tube may be brought into closer proximity to one another. Therefore,tissue growing into the occlusion device may not need to travel as faras it would if the occlusion device were circular in cross section, andmay result in less time to total occlusion of the fallopian tube.

In an embodiment, the occlusion device 10 has a substantially flatgeometry when unconstrained. Occlusion device 10 may be delivered in acatheter in a rolled-up configuration as illustrated in FIG. 19B. Onceexpelled from the delivery catheter, occlusion device 10 spreads out ina plane and forms a substantially flat geometry in the tube, asillustrated in FIG. 19C. In an embodiment, the planar edges 76 of theocclusion device can be formed with a wavy profile, which may assist inallowing the occlusion device 10 to fully spread out in a substantiallyplanar, flat configuration.

Referring again to FIG. 19A, occlusion device 10 may be formed of anopen walled frame 78. Open walled frame 78 may have a closed loop pathto avoid any having any sharp edges encumber the spreading out of thedevice 10 within the tube. In an embodiment, frame 78 is characterizedby a path having staggered levels of cutbacks 80. In an embodiment,frame 78 comprises at least three staggered levels of cutbacks 80. In anembodiment, occlusion device 10 may be cut from a flat nitinol sheet. Inanother embodiment, occlusion device 10 may be a conventional tubularocclusion device which has been flattened into a planar configuration.Occlusion device 10 may further be provided with a tissue in-growthmember similar to that in FIG. 10A and FIG. 10B. For example, occlusiondevice may be entangled with PET, silk or Nylon fibers.

In the foregoing specification, various embodiments of the inventionhave been described. It will, however, be evident that variousmodifications and changes may be made thereto without departing from thebroader spirit and scope of the invention as set forth in the appendedclaims. The specification and drawings are, accordingly, to be regardedin an illustrative sense rather than a restrictive sense. Hence, thescope of the present invention is limited solely by the followingclaims.

1. An occlusion device comprising: a proximal portion, a distal portion,and a traverse member connecting said proximal portion with said distalportion; a first plurality of arms outwardly expandable from saidproximal portion of said occlusion device; a second plurality of armsoutwardly expandable from said distal portion of said occlusion device;wherein said first plurality of arms and second plurality of arms areexpandable in opposing directions and overlap when expanded.
 2. Theocclusion device of claim 1, wherein said traverse member iscontractible.
 3. The occlusion device of claim 2, wherein said firstplurality of arms and second plurality of arms outwardly expand whilesaid traverse member contracts.
 4. The occlusion device of claim 3,wherein said traverse member is a spring.
 5. The occlusion device ofclaim 1, wherein said first plurality of arms are outwardly expandableby deflection from said distal portion, and second plurality of arms areoutwardly expandable by deflection from said proximal portion.
 6. Theocclusion device of claim 1, wherein said first plurality of arms areoutwardly expandable by deflection from said second plurality of arms,and said second plurality of arms are outwardly expandable by deflectionfrom said first plurality of arms.
 7. The occlusion device of claim 1,wherein said traverse member is rigid.
 8. The occlusion device of claim1, further comprising a tubular extension extending from said distalportion of said occlusion device.
 9. The occlusion device of claim 8,further comprising a radially expandable plug positioned over saidtubular extension;
 10. The occlusion device of claim 9, wherein saidradially expandable plug is a hydrogel polymer.
 11. The occlusion deviceof claim 9, wherein said radially expandable plug is a cylindricalsleeve.
 12. The occlusion device of claim 1, wherein said firstplurality of arms and second plurality of arms form an interlockingconfiguration.
 13. The occlusion device of claim 1, further comprising atissue in-growth material.
 14. The occlusion device of claim 13, whereinsaid tissue in-growth material is entangled within said occlusion device15. The occlusion device of claim 14, wherein said tissue in-growthmaterial is selected from the group consisting of PET, silk and Nylon.16. An occlusion device comprising: an open walled frame; wherein saidframe can be constrained within a catheter in a rolled up configuration,and deliverable within a fallopian tube in a substantially flatconfiguration.
 17. The occlusion device of claim 16, wherein said openwalled frame includes wavy edges on portions designed to engage a tubalwall.
 18. The occlusion device of claim 17, further comprising a tissuein-growth material.
 19. The occlusion device of claim 16, wherein saidopen walled frame has a close looped path.
 20. The occlusion device ofclaim 16, wherein said open walled frame is characterized by a pathhaving staggered levels of cutbacks.
 21. The occlusion device of claim20, wherein said open walled frame comprises at least three staggeredlevels of cutbacks.
 22. The occlusion device of claim 16, furthercomprising a tissue in-growth material.
 23. An occlusion devicecomprising: a tubular frame member expandable to an expandedconfiguration; a rod disposed within and running through the center ofsaid tubular frame member; wherein said rod fills at least half of thecross-sectional area of said tubular frame member when expanded to saidexpanded configuration.
 24. The occlusion device of claim 23, whereinsaid rod is substantially solid.
 25. The occlusion device of claim 23,wherein said rod is impermeable.
 26. The occlusion device of claim 23,wherein a surface of said rod is scored.
 27. The occlusion device ofclaim 23, further comprising lines of tissue in-growth material formedon a surface of said rod and extending radially from said rod.
 28. Theocclusion device of claim 27, wherein said tissue in-growth material isa series of fibers.
 29. The occlusion device of claim 27, wherein saidtissue in-growth material is a mesh.
 30. The occlusion device of claim27, wherein said tissue in-growth material is a porous material.
 31. Anocclusion device comprising: a tubular frame member including protrudingfeatures attached to said frame in a helical arrangement, wherein allprotruding features attached to said frame are arranged in said helicalarrangement.
 32. The occlusion device of claim 31, wherein saidprotruding features are triangular.
 33. The occlusion device of claim31, wherein said protruding features are wire-like prongs.
 34. Acontraception system comprising: an elongated shaft having a distal endportion and a lumen extending therein; and an occlusion devicerestrained within said lumen; wherein a surface of said distal endportion of said elongated shaft includes a plurality of shark skinoriented textures.
 35. The contraception system of claim 34, whereinsaid shark skin oriented textures have a triangular shape.
 36. Thecontraception system of claim 34, wherein said shark skin orientedtextures comprise leading and trailing edges having a curved,streamlined shape.
 37. A contraception system comprising: an elongatedshaft having a distal end portion and a lumen extending therein; a slitin said distal end portion of said elongated shaft; a wire expandablethrough said slit, and retractable into said slit; and an occlusiondevice restrained within said lumen.
 38. The contraceptive system ofclaim 37, wherein said wire is expandable through said slit by pushingsaid wire forward distally in said elongated shaft.